Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Editorial
. 2020 Oct 28;21(1):898.
doi: 10.1186/s13063-020-04828-8.

Prospective reporting of statistical analysis plans for randomised controlled trials

Karla Hemming  1 , Anna Kearney  2 , Carrol Gamble  2 , Tianjing Li  3 , Peter Jüni  4 , An-Wen Chan  5 , Matthew R Sydes  6
Affiliations
Editorial

Prospective reporting of statistical analysis plans for randomised controlled trials

Karla Hemming et al. Trials. .
No abstract available

PubMed Disclaimer

Conflict of interest statement

The authors declare they have no competing interests.

Comment on

References

    1. Gamble C, Krishan A, Stocken D, Lewis S, Juszczak E, Doré C, Williamson PR, Altman DG, Montgomery A, Lim P, Berlin J, Senn S, Day S, Barbachano Y, Loder E. Guidelines for the content of statistical analysis plans in clinical trials. JAMA. 2017;318(23):2337–2343. doi: 10.1001/jama.2017.18556. - DOI - PubMed
    1. Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin J, Doré C, Parulekar W, Summerskill W, Groves T, Schulz K, Sox H, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–207. doi: 10.7326/0003-4819-158-3-201302050-00583. - DOI - PMC - PubMed
    1. Spence O, Hong K, Onwuchekwa Uba R, Doshi P. Availability of study protocols for randomized trials published in high-impact medical journals: a cross-sectional analysis. Clin Trials. 2020;17(1):99–105. doi: 10.1177/1740774519868310. - DOI - PubMed
    1. [ICH E9 1998] International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use . ICH harmonised tripartite guideline: statistical principles for clinical trials E9. London, England: European Medicines Agency; 1998.
    1. Dwan K, Altman DG, Clarke M, Gamble C, Higgins JP, Sterne JA, Williamson PR, Kirkham JJ. Evidence for the selective reporting of analyses and discrepancies in clinical trials: a systematic review of cohort studies of clinical trials. PLoS Med. 2014;11(6):e1001666. doi: 10.1371/journal.pmed.1001666. - DOI - PMC - PubMed

LinkOut - more resources